Month: August 2015

I had the pleasure of attending the 2nd Annual ACI’s Women Leaders in Life Sciences Law meeting in Boston last week. While I originally registered to ensure that stay on top of the latest developments in the law that affect our Life Science community, I ended up getting a lot more out of the, for lack of a better word, “personal” disclosures, shared by the women leaders who spoke.

There were a lot of interesting exchanges and factoids, among them:

PhRMA has only 30 member companies.

Little-known effect of the ACA: Insurance companies have created “access tiers” for certain health plans so that, while the Affordable Care Act prevents them from denying one insurance for a pre-existing condition, only certain “tiers” will cover high-cost disease states. Consequently, the plan sold to a person who would have otherwise been denied, could cost more. I thought that the whole point of the “non-discrimination” clause was to to ensure :non-discrimination”?

22 US States have enacted their own, “Right to Try” (Abigail Alliance) laws. These laws allow patients to try unapproved drugs, after a successful Phase 1. There may be conflict with the FDA regs in some states but these conflicts are addressed on a case-by-case basis.

Five countries have enacted or updated new Global Transparency Laws in the past year. France, Denmark, Slovenia, Romania and Estonia have updated guidelines for paying any health care provider in those countries.

“No. But being the only woman in the room makes people remember you, for a long time” – Response to the following question, posed to a US District Court Judge, “Have there been any circumstances where being the only woman in the room, in a high-stakes meeting, actually contributed to a resolution or in some way helped further your cause?“

There was just not enough time to get into detail regarding those states that have passed “tissue property laws”, which restrict use of research tissue and bestow ownership of the tissues upon, in most cases, the patient, but those have to considered. We at CA will be doing a deep-dive into these new states laws and will provide an analysis here.

Thanks to the speakers who took the time to come to Boston for such a great conference; I am looking forward to next year’s meeting in Paris.